System and method for multi-channel intracranial pressure detection and monitoring and multi-channel device

Abstract

A system and method for non-invasive multi-channel intracranial pressure detection and monitoring is described. A solution for multi-channel detection of volume changes within the skull and processing of signals from multiple sensors in order to determine the intracranial pressure of a user with higher accuracy is disclosed. To this end, the invention proposes multiple sensors that can be positioned on the head of a user and communicate with a processing unit, wherein the sensors are arranged on a fixed structure. The sensors also have auxiliary sensors that contribute to the detection result. The invention belongs to the fields of medicine, biomedical science, neuroscience, physical quantity measurement and electrical engineering.

Description

Technical Field

[0001] This invention describes a solution for non-invasive multi-channel intracranial pressure detection and monitoring, seeking greater accuracy in detection results and allowing greater flexibility in signal detection because it enables both global and local analysis, in addition to allowing the detection of additional signals using biometric recognition units. This invention belongs to the fields of medicine, biomedicine, neuroscience, physical quantity measurement, and electrical engineering. Background Technology

[0002] Existing conventional methods for monitoring intracranial pressure (PIC) involve penetrating the skull and inserting a catheter through the skull and dura mater to perform the measurement. This highly invasive procedure carries the risk of contributing to intracranial hematoma, exacerbating cerebral edema, damaging the parenchyma, causing intracranial hemorrhage, and promoting intracranial infection, the latter being the most common complication observed in patients monitored more than one week post-surgery. Considering all the aforementioned drawbacks, the need to monitor PIC using at least one minimally invasive method that eliminates the complications arising from intracranial penetration is of great clinical importance, as it is opening up new areas of research regarding this vital physiological parameter. Therefore, there is a need to develop devices capable of detecting changes in the volume of a patient's skull, thereby allowing for accurate results regarding PIC morphology.

[0003] Several techniques exist for non-invasively measuring PIC; however, most of these techniques perform measurements using a frequency response / impulse response concept, which, for those skilled in the art, involves injecting a known signal into the skull and reading it after it has passed through the skull, thereby obtaining the ratio of the injected signal to the received signal. This is the case with patents WO9202174 and US2009234245, as well as many others. Accordingly, standardization and calibration are implemented so that PIC measurements can be performed by final modifications to the read signals. However, these concepts perform PIC measurements in a point-based manner—in other words, only in one area of ​​the patient's skull—so that the system cannot detect an increase in pressure in another area.

[0004] In addition, there are systems that measure the level of blood pressure or cerebrospinal fluid circulating in a patient's head, many of which use accelerometers to perform this measurement. Thus, the system correlates the measured pressure with the patient's intracranial pressure. However, these systems are prone to signal loss in measurement because they do not directly measure intracranial pressure. This type of system is validated in patent US2016081608.

[0005] Therefore, systems exist that measure PIC by volume changes / skull deformation, such as those in patents WO2013041973 and WO2019087148. In these solutions, the system uses sensors that identify volume changes in the skull and thus attributes these changes to the PIC's morphology. Such systems, unlike the others mentioned above, are based on the fact that the skull is not an extremely rigid and fixed structure, allowing the skull shell to deform based on the patient's intracranial pressure. However, these solutions do not offer the possibility of multi-channel acquisition of the PIC morphology signal, as this signal is incidentally extracted from different regions of the patient's skull.

[0006] Therefore, as can be seen from the literature reviewed, no documents were found that anticipated or implied the teachings of the present invention, and thus the solution proposed herein is novel and inventive relative to the prior art. Summary of the Invention

[0007] Therefore, the present invention aims to solve the problems of the prior art by integrating multiple signals detected by multiple biometric identification units (1) arranged in the user's head to generate several possibilities for visualizing the results from the detected PIC morphology. The biometric identification units (1) are arranged in different areas on the patient's head and consequently provide the measurement results to the processing unit (2).

[0008] In this sense, the present invention aims to improve the accuracy of data acquisition for non-invasively capturing intracranial pressure signals, and further enables the collection and processing of other user-related parameters from globally located biometric identification units, thereby allowing for different analyses based on these parameters. The visualization of the PIC morphology detected by several sensors at different locations around the skull achieves greater accuracy and reliability of the obtained results.

[0009] Furthermore, the present invention provides a biometric identification unit (1) consisting of at least one sensor for acquiring additional signals of volume change / skull deformation, such that these additional signals are compensated when calculating the PIC or used when performing quality verification on the channel, thereby allowing any interference in the measurement results to be checked.

[0010] In its first objective, the present invention discloses a system for non-invasive multi-channel intracranial pressure detection and monitoring of a user based on skull deformities, wherein the system comprises: an intracranial pressure detection and monitoring device including a plurality of biometric identification units (1) capable of being positioned on the user's head, the biometric identification units communicating with at least one processing unit (2), the processing unit (2) including a processor (2.1) communicating with a communication interface (2.2) for reading and processing signals from each biometric identification unit (1); and a receiver that operatively communicates with the processing unit (2) of the intracranial pressure detection and monitoring device.

[0011] In a second objective, the present invention discloses a non-invasive multi-channel intracranial pressure detection and monitoring device, the device comprising: a plurality of biometric identification units (1) communicating with at least one processing unit (2), the processing unit (2) including a processor (2.1) communicating with a communication interface (2.2) for reading and processing signals from each biometric identification unit (1); and at least one fixing structure (3) capable of being positioned on a user's head, wherein the plurality of biometric identification units (1) are radially distributed along the fixing structure (3).

[0012] In a third objective, the present invention discloses a method for non-invasive multi-channel intracranial pressure detection and monitoring of a user based on skull deformation, the method comprising the steps of: i) detecting multiple signals related to skull deformation of the user by means of an intracranial pressure detection and monitoring device comprising multiple biometric identification units (1) capable of being positioned on the user's head; ii) receiving the multiple signals related to the skull deformation via a communication interface (2.2), one or more signals related to the skull deformation being sent to a processor (2.1), wherein the communication interface (2.2) and the processor (2.1) are included in a processing unit (2); and iii) processing the one or more signals related to the skull deformation that generate intracranial pressure signals via the processor (2.1).

[0013] These and other objects of the present invention will be readily understood by those skilled in the art and will be described in detail below. Attached Figure Description

[0014] To better define and clarify the contents of this patent application, the following figures are shown:

[0015] Figure 1 An implementation scheme for a non-invasive intracranial pressure monitoring device is shown.

[0016] Figure 2An embodiment of an intracranial pressure monitoring device that is adjusted by a fixed structure (3) is shown.

[0017] Figure 3 An embodiment of an intracranial pressure detection device configured with a biometric identification unit (1) containing multiple sensors is shown.

[0018] Figure 4 A side view of one possible implementation of a biometric identification unit is shown.

[0019] Figure 5 A silhouette view of a possible implementation of a biometric identification unit is shown.

[0020] Figure 6 One possible implementation of a biometric identification unit that highlights the location of an auxiliary sensor is shown.

[0021] Figure 7.a and Figure 7.b The operation of the sensor performing volumetric recording is shown.

[0022] Figure 8 Different curves of signals obtained from volumetric sensors (1.4) at different locations on the user's head are shown.

[0023] Figure 9.a A possible implementation is shown with a cap for distributing multiple biometric identification units (1). Figure 9.b Another embodiment with a cap is shown, in which biometric identification units (1) are interconnected. Figure 9.c An embodiment of a cap with an upper structure having a press biometric identification unit (1) is shown.

[0024] Figures 10a to 1 Version 0.h illustrates an implementation of a biometric identification unit comprising multiple sensors having different displacement transducer alternatives.

[0025] Figure 11 A possible implementation of the system topology is shown, illustrating the energy and information flow diagram between protruding blocks.

[0026] Figure 12 One possible implementation of a system architecture emphasizing multiple channels and analog / digital converters is shown.

[0027] Figure 13 This paper illustrates one possible implementation of a system architecture that emphasizes multiple channels and analog / digital converters in a configuration that allows for an expanded number of channels.

[0028] Figure 14A block diagram highlighting the use of multichannel processing performed by acquiring information from environmental sensors and biometric identification units is shown.

[0029] Figure 15 Several PIC morphology curves obtained at different locations on the human head are shown.

[0030] Figure 16 The PIC morphology curve is shown, obtained through non-invasive measurement results generated by multi-channel processing.

[0031] Figure 17 A representative flowchart of one implementation scheme for calculating channel quality metrics is shown.

[0032] Figure 18 An exemplary graph showing the effect of the volumetric recording signal on the displacement signal is shown.

[0033] Figure 19.a An exemplary block diagram for acquiring two signals is shown, and Figure 19.b The waveform of the acquired signal is shown.

[0034] Figure 20.a An exemplary block diagram for compensating for the delay between two signals is shown, and Figure 20.b The waveform of the obtained signal is shown.

[0035] Figure 21.a An exemplary block diagram for resampling and interpolating one of the signals is shown, and Figure 21.b The waveform of the obtained signal is shown. Detailed Implementation

[0036] The following description is presented by way of example and does not limit the scope of the invention, and will make the purpose of this patent application clearer.

[0037] For the purposes of this invention, "volume change of the skull" or "skull deformation" refers to the deformation of the skull shell caused by changes in intracranial pressure in the user. It should be noted that this deformation can be positive or negative; in other words, both expansion and contraction can occur.

[0038] In its first objective, the present invention discloses a system for non-invasive multi-channel intracranial pressure detection and monitoring of a user based on skull deformities, wherein the system comprises: an intracranial pressure detection and monitoring device including a plurality of biometric identification units (1) capable of being positioned on the user's head, the biometric identification units communicating with at least one processing unit (2), the processing unit (2) including a processor (2.1) communicating with a communication interface (2.2) for reading and processing signals from each biometric identification unit (1); and a receiver operationally communicating with the processing unit (2) of the intracranial pressure detection and monitoring device.

[0039] For the purposes of this invention, "multi-channel" refers to the fact that the solution proposed herein operates with more than one sensor device capable of capturing signals related to intracranial pressure and thus obtaining signals of skull deformation in different regions of the user's head. These signal acquisitions can either all occur simultaneously, operating in parallel, or operate synchronously, with one or more sensors operating sequentially.

[0040] Multiple biometric identification units (1) are defined by including multiple sensors, at least one of which is capable of detecting volume changes in the skull and converting mechanical forces applied to sensory organs into electrical signals. The multiple sensors operate continuously, are radially distributed along the user's head, and can be equally spaced or positioned at specific points for detecting point intracranial pressure in several regions of the skull. In one embodiment, the biometric identification unit (1) includes displacement sensors (1.1). These displacement sensors (1.1) can sense mechanical loads—both positive and negative—and convert mechanical energy generated by changes in PIC (conductively coupled plasma pressure) into electrical energy through capacitance, inductance, optics, piezoelectricity, resistance changes, and / or through ultrasound, fiber optics, interferometry, radar, changes in skull bioimpedance, or any combination of these techniques.

[0041] In one embodiment, the non-invasive multi-channel intracranial pressure detection device is provided with a plurality of biometric identification units (1) distributed along a fixed structure (3), the fixed structure being adjustable around the skull in a non-invasive manner.

[0042] In one embodiment, the biometric identification unit (1) includes a contact sensor (1.2). One function of this sensor is to provide information about the interface and quality of contact between the corresponding biometric identification unit (1) and the head portion receiving displacement by verifying, for example, contact with human skin. This process reduces errors or inaccuracies caused by poorly established contact due to intermediate materials (such as hair) between the skin and the biometric identification unit (1). In one embodiment, the contact sensor (1.2) is a temperature sensor, wherein, for example, based on the obtained temperature data, it can be verified whether the temperature is close to the expected temperature of human skin. With the aid of the temperature sensor, temperature changes between multiple channels of the system can also be measured and calculated to examine the temperature at different points on the patient's head. In another embodiment, the contact sensor (1.2) is an electrobiopotential sensor, which operates with a faster and more dynamic response to obtain the relative potential between the system channels (of natural bodily origin). In another embodiment, the contact sensor (1.2) is a continuous electrobioimpedance sensor in which a low-intensity current is applied between the channels to calculate the relative impedance of the channels over time to sense changes in the relative contact between the displacement sensor (1.1) of the biometric identification unit and the user’s head.

[0043] In one embodiment, the multiple biometric identification units (1) include a plethysmography sensor (1.4). This sensor is equipped with a light emitter (1.4a) and a photodetector (1.4b), and has the function of detecting peripheral extracranial blood circulation (6) in a specific location on the user's head, and thus using its data, for example, to eliminate possible noise in the data obtained by the displacement sensor (1.1), thereby obtaining a better PIC morphology. The sensor operation depends on the reflection of light at a specific wavelength in oxyhemoglobin cells present in the blood, and this reflection is acquired by the photodetector (1.4b) and is proportional to the number of these cells.

[0044] In one embodiment, the plurality of biometric identification units (1) include an inertial sensor (1.5). The sensor is a nine-degree-of-freedom IMU (1.5) having: three accelerometers capable of measuring changes in linear velocity in three orthogonal directions within a defined space by the process of converting kinetic energy into electrical energy; three gyroscopes capable of measuring rotation in three orthogonal directions within a defined space by changes in angular displacement; and three magnetometers capable of measuring changes in magnetic field in three orthogonal directions within a defined space by physical phenomena (e.g., emphasizing the Hall effect).

[0045] In one embodiment, the plurality of biometric identification units (1) includes a plurality of additional embedded sensors that function to monitor environmental conditions with complementary data to optimize PIC morphological measurement results. For illustrative purposes, these plurality of embedded sensors include at least one of the following: a hygrometer capable of measuring air humidity; a barometer capable of measuring atmospheric pressure in the patient's monitoring environment; a thermometer capable of measuring ambient temperature; an embedded inertial sensor having a topology similar to that used by the inertial sensor (1.5) shown in the biometric identification unit (1); or a combination thereof.

[0046] The processing unit (2) includes a processor (2.1) and a communication interface (2.2). The communication interface (2.2) is any hardware or software component implemented within the processor (2.1) itself or as a separate component capable of receiving signals from all biometric identification units (1) and forwarding those signals to the processor (2.1). In one embodiment, the communication interface (2.2) receives all signals from the displacement sensor (1.1) of the biometric identification unit (1). In this embodiment, signals from auxiliary sensors of the biometric identification unit (1) are forwarded directly to the processor or via another communication interface.

[0047] In one implementation, the processor (2.1) selects one or more signals from the biometric identification unit (1) by means of a selector element. Thus, the selector element allows the signals to be processed and / or analyzed globally, locally, or precisely. Globally refers to the fact that all signals are read and processed; locally refers to some signals from only one or more specific regions of the skull; and precisely refers to signals from a single sensor. Furthermore, the selector element is controlled by the processor (2.1) such that the processor (2.1) sends a channel selection command to the selector element. Moreover, this channel selection command can be issued by a component external to the device or system—for example, by the receiver itself or by the system operator.

[0048] In one embodiment, the selector element can be a hardware or software component capable of selecting one or more channels. In one embodiment, the selector element is a software component programmed into the processor (2.1) itself, which selects the channel to be read or processed upon receiving an instruction from the processor (2.1). For example, the selector element is a channel enable / disabler. In another embodiment, the selector element is a pre-configured digital filter for channel separation.

[0049] In one embodiment, the processor (2.1) receives multiple signals in the form of digital signals from the biometric identification unit (1) and from environmental sensors. Therefore, in this embodiment, the communication interface (2.2) includes multiple analog-to-digital converters that can be arranged in different topologies to receive and convert signals from all the biometric identification units (1). The manner in which the topologies are established defines the number of biometric identification units (1) simultaneously acquired by the processing unit (2), thereby achieving higher information accuracy.

[0050] The processor (2.1) is designed to receive all signals generated by the multiple biometric identification units (1) and embedded environmental sensors, and to process the signals received by the multiple displacement sensors (1.1), contact sensors (1.2), volumetric sensors (1.4), inertial sensors (1.5), and environmental sensors in several ways to produce measurements of changes in skull volume according to the operator's needs for the system used to monitor and manage intracranial pressure. In one embodiment, signals received from the multiple biometric identification units (1) are processed in parallel by the processor (2.1). In another embodiment, signals received from the multiple biometric identification units (1) are processed serially by the processor (2.1). In yet another embodiment, only signals defined by the operator of the intracranial pressure monitoring and detection system are processed by the processor (2.1). Processing of signals selected by the system operator includes individual and joint mathematical and statistical manipulations to obtain optimized PIC morphological curves. Furthermore, the processing performed refers to generating one or more waveforms associated with the signals provided by the biometric identification units (1).

[0051] In one implementation, the processing unit (2) acquires one or more signals from one or more sensors present in a plurality of biometric identification units (1) and performs individual processing on each of the channels, wherein each channel is considered to be at least one biometric identification unit (1). These processed signals result in the optimization of data of interest for monitoring the PIC morphology of a patient and are transmitted via a transmitter operating in a predetermined communication protocol.

[0052] In one embodiment, the processor (2.1) includes a signal compensation tool that attenuates signals from the contact sensor (1.2), the plethysmography sensor (1.4), and / or the inertial sensor (1.5) based on the intracranial pressure signal. In this sense, the processor (2.1) uses the contact signal, the plethysmography signal, and the motion signal to attenuate any noise that might interfere with the skull deformation signal, thereby compensating for it.

[0053] In one implementation, the processor (2.1) or receiver includes a channel signal quality index generation tool, which generates a quality index for each biometric unit (1) of the intracranial pressure detection and monitoring device based on signals from a displacement sensor (1.1), a contact sensor (1.2), a plethysmography sensor (1.4), and / or an inertial sensor (1.5). Thus, an index is assigned to each channel representing the contribution of the contact signal, plethysmography signal, and / or movement signal to the overall volume change of the patient's skull, and further verifies whether the detected displacement signal has any interfering components, such as due to poor positioning of the biometric unit (1). The index for each channel is then multiplied by the displacement signal detected by the displacement sensor (1.1) for the corresponding channel, allowing verification of the quality of the measurement results for the corresponding channel.

[0054] In one embodiment, the processing unit (2) has a transmitter that communicates with the processor (2.1) to receive processed skull deformation signals and transmit them to a receiver. In one embodiment, this transmitter is a wired communication board. In another embodiment, the transmitter is a wireless communication board that transmits information via a predetermined protocol.

[0055] In one embodiment, the receiver is a component adapted to receive data from a processing unit (2), which may be a monitoring unit having a display for displaying data. Alternatively, the receiver may be a cloud database unit that receives signals from the processing unit (2). Furthermore, the signals transmitted by the processing unit (2) may be provided to multiple receivers (e.g., local receivers in a hospital / laboratory environment) and cloud receivers (such as databases).

[0056] Another object of the present invention is a non-invasive multi-channel intracranial pressure detection and monitoring device, comprising: a plurality of biometric identification units (1) communicating with at least one processing unit (2), the processing unit (2) including a processor (2.1) communicating with a communication interface (2.2) for reading and processing signals from each biometric identification unit (1); and at least one fixing structure (3) capable of being positioned on a user's head, wherein the plurality of biometric identification units (1) are radially distributed along the fixing structure (3). The distribution of the biometric identification units (1) in the fixing structure (3) may be peripheral or surface-mounted.

[0057] In one embodiment, the processing unit (2) is positioned on a fixed structure (3). In one embodiment, a plurality of biometric identification units (1) communicate with the processing unit (2) by means of wires housed within the fixed structure (3). In one embodiment, the plurality of biometric identification units (1) and the processing unit (2) communicate wirelessly.

[0058] In one embodiment, the plurality of biometric identification units (1) include a support (1.3). The support has the function of forming a connection between the biometric identification unit (1) and the fixed structure (3) in such a way that there is no interference or minimizes interference in the acquisition of sensors present in the biometric identification unit (1) and establishes constant stability relative to the fixed structure (3).

[0059] In one embodiment, the fixation structure (3) includes straps interconnected by an adjustment device (4) and at least one tension sensor. The fixation structure (3) is designed to be adjustable to the shape of the skull and has high sensitivity while maintaining the integrity of the skull in cases of patient fragility. The adjustment device (4), together with the tension sensor, can be used as a metric to ensure that the initial pressure set in the head meets the minimum initial conditions for proper monitoring of the PIC. In another embodiment, the fixation structure (3) is made of a resilient or adjustable material in the shape of a cap, which allows for the positioning of multiple biometric units (1) at specific locations on the head. In both embodiments, the fixation of the biometric units (1) to the fixation structure (3) is implemented by a support (1.3) associated with the biometric units (1) to provide greater stability during use and to avoid changes in the operational static state and tampering with the monitoring results.

[0060] In one embodiment, the biometric identification unit (1) includes a displacement sensor (1.1) attached to at least one unit support (1.3), which can be associated with a fixed structure (3). This configuration allows the greater stability provided by the unit support (1.3) to also be transferred to the displacement sensor (1.1).

[0061] In addition, the biometric identification unit includes at least one contact sensor (1.2), at least one volumetric sensor (1.4), and at least one inertial sensor (1.5). The sensors have been previously defined.

[0062] In one embodiment, a contact sensor (1.2) and a plethysmography sensor (1.4) are arranged in a first region (A), which is the region closest to the user's head. For example, the first region (A) is in contact with the user's head. This arrangement is implemented to facilitate contact or proximity of both the contact sensor (1.2) and the plethysmography sensor (1.4) to the skin. The contact sensor (1.2) allows for examination of the interface and quality of contact between the biometric unit (1) and the head portion receiving displacement, for example, by a temperature sensor, to verify whether the temperature is close to the expected human skin temperature, wherein this process reduces errors or inaccuracies caused by improperly established contact due to the presence of intermediate materials (such as hair) between the skin and the biometric unit (1). The plethysmography sensor (1.4), which depends on the reflection of light at a specific wavelength in oxyhemoglobin cells present in the blood and is designed for higher accuracy of results, is arranged close to the patient's head.

[0063] In one embodiment, the unit support (1.3) is arranged opposite to the first region (A), such that the displacement sensor (1.1) is arranged between the first region (A) and the unit support (1.3).

[0064] In one embodiment, a displacement sensor (1.1) is positioned between two flat, cylindrical ends—a movable base and a unit support (1.3). A contact sensor (1.2) and a volumetric sensor (1.4) are both arranged in the movable base, which is closer to the first region (A). In the implemented configuration, the emitter and photodetector of the volumetric sensor (1.4) are arranged at the center of the outermost surface of the movable base, while the contact sensor (1.2) is arranged in a ring shape on the outer portion of the movable base. Additionally, an inertial sensor (1.5) is placed on the unit support (1.3), closer to the fixed structure (3).

[0065] Another object of the present invention is a method for non-invasive multi-channel intracranial pressure detection and monitoring of a user based on skull deformation, the method comprising the following steps: i) detecting multiple signals related to skull deformation of the user by means of an intracranial pressure detection and monitoring device including multiple biometric identification units (1) capable of being positioned on the user's head; ii) receiving the multiple signals related to skull deformation through a communication interface (2.2), one or more signals related to skull deformation being sent to a processor (2.1), wherein the communication interface (2.2) and the processor (2.1) are included in a processing unit (2); and iii) processing the one or more signals related to skull deformation that generate intracranial pressure signals by the processor (2.1).

[0066] In one implementation, the step of detecting multiple signals is performed by means of the previously described multi-channel detection device. The detection of multiple signals can be performed in parallel, that is, all biometric identification units (1) perform detection synchronously or serially.

[0067] In one embodiment, the communication interface (2.2) receives all signals from the displacement sensor (1.1) of the biometric identification unit (1). In this embodiment, signals from auxiliary sensors of the biometric identification unit (1) are either directly forwarded to the processor or via another communication interface.

[0068] Furthermore, the method includes a channel selection step using a selector element, wherein the processor (2.1) selects one or more signals related to skull deformation from one or more biometric identification units (1). This channel selection step allows for global, local, or precise processing and / or analysis of the signals. Additionally, this channel selection step can be performed at the request of a system operator or autonomously by the processor (2.1) itself using existing configurations, wherein the processor (2.1) can be configured to select one or more channels based on a condition detected by one of the sensors in the biometric identification unit (1).

[0069] Furthermore, the method of the present invention includes the step of generating a channel signal quality index, which is generated for each of a plurality of signals associated with skull deformation, wherein the channel signal quality index is generated based on displacement signals, contact signals, volumetric recording signals, and / or movement signals from a plurality of biometric identification units (1). In one embodiment, this index is generated by a processor (2.1), by a receiver, or by an external processing unit linked to the receiver.

[0070] In one implementation, a quality index is assigned to each channel, representing the contribution of the contact signal, plethysmography signal, and / or motion signal to the overall volume change of the patient's skull, and further verifying whether the detected displacement signal has any interfering components. The index for each channel is then multiplied by the displacement signal detected by the displacement sensor (1.1) for that channel, allowing verification of the quality of the measurement results for that channel. Given this index, the processor (2.1) or system operator can select a channel with higher detection quality via the selector element; in other words, a channel with less contribution from the contact signal, plethysmography signal, and / or motion signal. Accordingly, measurements of skull deformation can be obtained at points with less interference from these signals.

[0071] In one implementation, the generation of the intracranial pressure signal in the processing step refers to the generation of one or more waveforms associated with the signal provided by the biometric identification unit (1). Generating PIC-shaped waveforms and signals based on displacement signals can follow concepts already used in the prior art.

[0072] Furthermore, mathematical / statistical tools can be applied in this processing step to evaluate multiple signals. For example, the signals detected by all biometric identification units (1) or only a predefined portion can be averaged. Additionally, parameters concerning different regions of the skull can be extracted based on the signals acquired by the biometric identification units of the corresponding regions.

[0073] Unlike systems known from the prior art, this invention, through a non-invasive multi-channel intracranial pressure device, allows for accurate monitoring of intracranial pressure adjustments, detection of cranial expansion at multiple points on the skull, high-precision acquisition of intracranial pressure, processing of detected signals to generate accurate pressure, and smooth and continuous data transmission. Furthermore, this solution aims to allow for the localization of areas generating the greatest volumetric changes in the skull.

[0074] Example

[0075] The embodiments shown herein are merely examples of one of many ways in which the invention can be carried out, and do not limit its scope.

[0076] Figure 1 One of the many variant embodiments derived from the present invention is shown. Multiple biometric identification units (1) of the intracranial pressure detection device are formed by displacement sensors (1.1) arranged at equal intervals and around the periphery of a fixed structure (3). The patient's skull applies a load to each sensor such that the force (P) applied to the displacement sensor (1.1) has the direction and orientation of the normal vector forming the sensor. It should be noted that the force (P) can be both positive and negative; in other words, the skull can expand or contract its volume.

[0077] The normal vector is defined as the force (P) perpendicular to the collision area, so that all applied pressure is detected and converted into an electrical signal.

[0078] The processing unit (2) has: a communication interface (2.2) – in this case, a multi-sensor analog input regulator (multi-sensor analog front end) that receives in parallel all signals generated by multiple biometric identification units (1); a processor (2.1) that processes all signals generated by skull deformation; and a transceiver for receiving and sending the generated data via wireless communication with the receiving system.

[0079] The fixed structure (3) is composed of a material that transmits all the mechanical energy generated by skull deformation to multiple biometric identification units (1). The adjustment device (4) and tightness sensor are used as initial condition references and are used as a measurement system by adjusting the fixed structure (3) around the skull perimeter, as in... Figure 2 As shown in the figure.

[0080] In one implementation scheme Figure 3 A biometric identification unit (1) consisting of various sensors (including volumetric sensors and contact sensors) distributed throughout the fixation structure (3) is shown. The use of the biometric identification unit (1) containing a large number of sensors provides better access to information, enabling more accurate estimations of the PIC morphology. In this embodiment, the fixation structure (3) is in the form of a stretchable and adjustable strip, allowing the device to be fitted and positioned on the user's head and used for more efficient transmission of mechanical energy generated by PIC changes, while maintaining patient integrity in cases of skull fragility.

[0081] Figure 4 A side view of a biometric identification unit is shown, comprising a displacement sensor (1.1), a movable base—where a contact sensor (1.2) is positioned—and a unit support (1.3) for attachment to a fixed structure (3), such that the displacement sensor (1.1) is positioned between the movable base and the unit support (1.3). In this embodiment, the contact sensor (1.2) is a temperature sensor in the form of a ring, capturing the temperature of the area it is contacting. The displacement sensor (1.1) has a specialized form for converting changes in mechanical energy occurring within the skull into electrical energy through different types of transducers, which can be resistive, inductive, capacitive, or piezoelectric, and are acquired through interferometry, optical signal changes via optical fibers, radar systems, and ultrasonic reception.

[0082] Figure 5 This is a contour view of the described biometric identification unit, highlighting the location of the externally visible sensors and indicating the area of ​​presence (A) – the area closest to the user's head. This arrangement allows both the temperature sensor (1.2) and the volumetric sensor (1.4) to be positioned in the area closest to the head, preferably – but not necessarily – in contact with the user's skin.

[0083] Figure 6 The location selection for the plethysmography sensor is shown, which performs the emission and acquisition of light at a predefined wavelength to capture the presence of peripheral extracranial blood circulation (6), by Figure 7.a and Figure 7.bThe illustrated process. In these figures, the amount of oxyhemoglobin present in the peripheral extracranial blood circulation (6) can be estimated by reflecting the amount of light previously emitted by the light emitter (1.4a) and acquired by the photodetector (1.4b), the amount of which increases proportionally with the amount of the aforementioned type of cells. In an embodiment, the light emitter is an LED.

[0084] Still in Figure 6 The presence of an inertial sensor (1.5) can be observed; this inertial sensor is a 9-DOF IMU within the unit support (1.3) of the biometric identification unit. In this implementation, the sensor consists of three accelerometer channels, three gyroscope channels, and three magnetometer channels, which perform measurements of the position and movement of the head and each of the biometric identification units (1) in which they are located. This component is crucial for correlating limb and sensor movements with the acquired PIC morphological signals, thereby validating and correcting the data and performing more accurate analysis.

[0085] Figure 8 Different curves are shown, generated by measurements from plethysmography sensors (1.4) in different regions of the user's head. These sensors acquire pulses from the peripheral extracranial blood circulation (6) and identify the presence of blood vessels in the patient's head in the region where the biometric identification unit (1) is located. Figure 8 The example shows three curves. In the first curve, there is no peripheral circulation in the region where the sensor is located. In the second curve, the sensor is precisely positioned above the blood vessel, thus detecting a high level of peripheral circulation. And in the third curve, the sensor is in a region close to the blood vessel with peripheral circulation, thus detecting its presence, but at a lower intensity.

[0086] Figures 9.a to 9.c One embodiment is illustrated, in which a cap is used as a fixing structure (3) to obtain the contour of the PIC morphology curve along the entire head of the patient, thereby covering a larger area compared to strips that may appear in other embodiments. In these figures, an adjustment device (4) can be seen to securely adjust the cap to the head and prevent movement of the sensors relative to the body, and the processing unit (2) remains attached to the cap. Figure 9.a In this design, the connection between the biometric identification unit (1) and the processing unit (2) is housed beneath the cap fabric. Figure 9.b In this embodiment, the connection between the biometric identification unit (1) and the processing unit (2) is superficially arranged to the cap. In both embodiments, for illustrative and easy-to-view purposes, the figures show an exemplary arrangement where the biometric identification unit (1) is arranged under the cap. In this sense, Figure 9.cAn alternative with an additional structure covering the cap to press the biometric identification unit (1) against the patient's head is shown. Thus, according to the adjustment device (4), the additional structure can be used to better position / press the biometric identification unit (1).

[0087] Figures 10a to 1 0.h illustrates an embodiment of all sensors included in each of the biometric identification units (1). Among them, it can be observed that, in this case, temperature (e.g., from a contact sensor) and volumetric mapping, as well as positional characteristics via the IMU, are commonly acquired. Furthermore, these units are distinguished by displacement transducers, which are used in… Figure 10.a The middle can be a capacitor source, in Figure 10.b The middle is resistive, in Figure 10.c The middle is inductive, in Figure 10.d The middle is piezoelectric, in Figure 10.e The middle is through ultrasound, in Figure 10.f The middle is optical fiber, in Figure 10.g The middle part is the interferometry, and in Figure 10.h it is through the radar sensor.

[0088] Figure 11 A topology of a device containing a source supplying energy to a system is shown, comprising multiple biometric identification units (1) that send their signals through a signal amplification and analog filtering process. These signals are then converted into digital signals that can be interpreted by a processor (2.1), which in turn sends the processed data to a qualified receiver. In this topology, due to the technology used, the raw digital signals generated by the inertial sensor (1.5) and volumetric sensor (1.4) are sent directly to the processor without undergoing conversion and preprocessing. Alternatively, signals from the inertial sensor (1.5) and volumetric sensor (1.4) may be passed through an analog-to-digital converter even before being directed to the processor (2.1).

[0089] Figure 12 The application of it is shown Figure 11 The system architecture of the illustrated topology emphasizes the presence of several channels located at different positions on the head. Each channel signal undergoes an analog processing step—in this case, amplification and filtering—before being sent to the communication interface (2.2). The communication interface (2.2) is equipped with multiple analog-to-digital converters, such that signals from all biometric identification units (1) are converted into digital signals. Figure 12 In this topology, only the displacement sensor (1.1) signal is transmitted through the analog / digital converter of the communication interface (2.2).

[0090] In addition to the signals from the displacement transducer, the processor (2.1) receives digital signals from each of the biometric identification units (1) from the volumetric sensor, inertial sensor (1.5), and contact sensor (1.2), and further receives information from embedded sensors such as thermometers, barometers, hygrometers, and inertial sensors to capture signals characterizing environmental conditions. All information is acquired and processed in the processor and sent to the transmitter to transmit the data to a specific receiver.

[0091] Still in Figure 12 In this embodiment, the biometric identification units are sorted by the processor according to channels, such that the displacement sensor (1.1), contact sensor (1.2), volumetric sensor (1.4), and inertial sensor (1.5) of a given biometric identification unit are assigned to a specific channel (e.g., channel 1). Therefore, the processor performs clustering to correlate all signals from the different sensors of the corresponding biometric identification unit to a given channel, although as in... Figure 12 As shown, the contact sensor (1.2), volumetric sensor (1.4), and inertial sensor (1.5) are not transmitted through the interface (2.2) together with the displacement sensor (1.1). It should be understood that this embodiment illustrates one of many possibilities for system topologies to reproduce the concept of the invention, without limiting the purposes claimed herein.

[0092] Figure 13 An embodiment is shown, which is similar to Figure 12 However, the communication interface (2.2) includes a larger number of analog-to-digital converters, thus forming a daisy-chain configuration for reading a larger number of analog channels. This allows for the acquisition of more information as the number of channels increases, enabling the generation of optimized PIC morphology curves. In this configuration, 16 eight-channel analog-to-digital converters can simultaneously read up to 128 sensors—including multiple displacement sensors (1.1), auxiliary biometric sensors such as contact sensors (1.2), volumetric sensors (1.4), inertial sensors (1.5), and environmental sensors.

[0093] Figure 14 A block diagram emphasizing the presence of several channels is shown, each representing multiple sensors to be acquired and tuned individually. These are sent to a processor to perform multi-channel processing on each of the sensors in each channel, with the aim of obtaining more information about the biometric characteristics and environment that lead to the acquisition of optimized PIC morphology curves.

[0094] Figure 15The graph represents all signals detected by the patient's multiple biometric identification units (1). In this graph, displacement signals related to skull deformation are processed and represented as displacement versus time.

[0095] Figure 16 A graph representing an embodiment of statistical processing with the average value of all signals processed by the processing unit (2) is shown as a relationship between displacement and time.

[0096] The system of the present invention is capable of generating a channel signal quality index for each of the channels based on the signals detected by all biometric identification units. The index can be generated by the processor (2.1) or by components external to the device, and can even be generated according to instructions from the system operator.

[0097] Therefore, each channel is assigned an index representing the contribution of the contact signal, plethysmography signal, and / or motion signal to the overall volume change of the user's skull, in addition to considering the displacement signal itself. The index for each channel is then multiplied by the displacement signal detected by the displacement sensor (1.1) for that channel, allowing verification of the quality of the measurement results for that channel. The equations below illustrate an example of using these indices:

[0098]

[0099] in, n It is a channel indicator. Dn The measurement results are from the displacement sensor (1.1), and QSn It refers to the channel n The quality index is represented by a nonlinear equation derived from the contributions of the contact sensor (1.2), volumetric sensor (1.4), and inertial sensor (1.5). The index can be generated using... Figure 17 The flowchart in the diagram is used to represent this.

[0100] QSn The calculation of channel quality indicators takes into account the biometric identification unit. n The signals and / or parameters read. For illustrative purposes, they can generally be calculated using the expressions below. QSn index:

[0101]

[0102] Among them, component "α" n “β” n “γ” n “δ” n “ε” n "ζ" n"etc." are biometric identification units n The signals and / or parameters read by the sensors. The terms "a", "b", "c", "d", "e", "f", etc., are coefficients that can be established theoretically, experimentally, and / or using machine learning techniques. In the case of experiments or machine learning, these coefficients are established in preliminary in vivo experiments. It is worth mentioning that this embodiment allows for the inclusion of other signals and / or parameters that can be read by the biometric identification unit, and is not limited to the signals used herein.

[0103] In one embodiment, which includes displacement signals, contact signals, volumetric recording signals, and movement signals, it is used to obtain QSn The equation for the quality index can be described as follows:

[0104]

[0105] in, PPG ampn Volumetric recording signal amplitude; PPG dcn : Average volumetric signal level; D ampn : Amplitude of the displacement signal; D dcn The average level of the displacement signal; Gyro Xn : Gyroscope X-axis signal; Gyro Yn : Gyroscope Y-axis signal; Gyro Zn : Gyroscope Z-axis signal; Mag Xn Magnetometer X-axis signal; Mag Yn : Magnetometer Y-axis signal; Mag Zn : Magnetometer Z-axis signal; Acc Xn : Accelerometer X-axis signal; Acc Yn : Accelerometer Y-axis signal; Acc Zn : Accelerometer Z-axis signal; Cont n : Contact sensor signal.

[0106] There is also the use of nonlinear equations for calculation. QSn An alternative to the indicator is that the coefficient is described in the following form:

[0107]

[0108] In the same case, the signals and / or parameters read by the biometric identification unit can also be written as follows, where only the volumetric sensor amplitude signal is exemplified, and it applies to all other signals.

[0109]

[0110] Therefore, given this metric, the processor (2.1) or system operator can select a channel with higher detection quality via a selector element; in other words, a channel with less interference from the displacement signal—which may be caused, for example, by poor positioning of the biometric identification unit (1) on the user's head—and less contribution from the contact signal, volumetric signal, and / or movement signal. Accordingly, measurements of skull deformation can be obtained at points with less interference from these signals.

[0111] Therefore, the processor (2.1) has a signal compensation tool designed to attenuate the contributions detected by the contact sensor (1.2), volumetric sensor (1.4), and inertial sensor (1.5). Return to Figure 8 An example in the example shows curves generated by measurements from volumetric sensors (1.4) in different regions of the user's head, which can be used to remove components or noise from the measurement results.

[0112] The presence of an additional component of peripheral extracranial blood circulation (6) in the PIC morphology signal obtained by the biometric identification unit (1) can be inferred from the signal obtained by the plethysmography sensor (1). This additional component may have a negative impact on the non-invasive PIC curve. In one embodiment where a significant contribution of peripheral extracranial blood circulation (6) is detected, the discussed impact on the PIC morphology signal obtained from the biometric identification unit (1) is reduced in the final analysis performed to reduce / subtract the presence of this component from the peripheral blood circulation of the PIC morphology.

[0113] The compensation tool in this embodiment uses calculations. QSn Quality indicators. Only the influence of volumetric recording signals is considered, such as in... Figure 8 The diagram shows the use of three channels of the biometric identification unit (1), where 1 – no peripheral circulation; 2 – large influence of peripheral circulation; and 3 – moderate influence of peripheral circulation. In this sense, QSn The indicators can be arbitrarily assigned as follows: QS1 =1.0; QS2 =0; and QS3 =0.1. In Figure 18An exemplary view showing the effect of these peripheral circulation signals on the displacement signal can be seen, where the PICNI signal represents the morphology of intracranial pressure. Clearly, the signals from D2 and D3 differ from those collected by D1.

[0114] In this embodiment, only the volumetric recording signal is considered; however, it is clear that this process is applicable to other signals collected by the biometric identification unit.

[0115] To achieve the calculation and ratio between multiple signals of the biometric identification unit (1) of the system, processing and synchronization steps of the received signals are performed. Different signals can be received at different times and acquisition rates. The communication delay between each sensor and the processor (2.1) is compensated so that the signals are synchronized in time. The signal with the lowest acquisition rate is resampled through an interpolation process, increasing the number of points and synchronizing point by point with the signal with the highest acquisition rate.

[0116] To illustrate and demonstrate this step, consider two signals collected by two sensors at different acquisition rates and with a time delay between them. Signal acquisition is achieved through... Figure 19.a The diagram is shown, where it can be verified that the X and Y components of signal 1 are sampled at a rate of 2000 samples / second, and the X and Y components of signal 2 are sampled at a rate of 1000 samples / second, with a time delay of 5ms. The waveform can be... Figure 19.b It was seen in the middle.

[0117] Then, delay compensation is implemented between the two signals, such as in Figure 20.a The diagram in the middle Figure 20.b This can be seen in the waveform. Therefore, after time compensation, the signal with the lowest sampling rate undergoes interpolation, in this case using splines, to calculate other points, producing a signal with the same number of points as the signal with the highest sampling rate. This step can be achieved by... Figure 21.a Block diagram (where waveforms are illustrated in) Figure 21.b (to verify)

[0118] In this context, it should be immediately clarified that, based on the disclosure of the present invention, those skilled in the art will be able to consider other ways of implementing the invention that differ from the merely illustrative methods described above, but such forms may be considered to fall within the scope of the appended claims in cases of commercial use.

Claims

1. A system for non-invasive multi-channel detection and monitoring of intracranial pressure in a user based on skull deformation, characterized in that, The system includes: a. A multi-channel device for detecting and monitoring intracranial pressure, comprising multiple biometric identification units (1), the device including a fixation structure (3) capable of being positioned on the user's head. The plurality of biometric identification units (1) are arranged on different regions of the user's head, and each biometric identification unit (1) includes at least one displacement sensor (1.1), which individually detects skull deformation from different regions of the user's head, the skull deformation being related to the user's intracranial pressure. The plurality of biometric identification units (1) are configured to communicate with at least one processing unit (2), the processing unit (2) including a processor (2.1) communicating with a communication interface (2.2) for reading and processing signals from each biometric identification unit (1). The communication interface (2.2) is configured to receive signals of skull deformation from each biometric identification unit (1). The processor (2.1) includes a selector element that selects signals from one or more biometric identification units (1) regarding skull deformation; and b. A receiver that communicates operationally with the processing unit (2) of the device.

2. The system according to claim 1, characterized in that, Each biometric identification unit (1) further includes at least one contact sensor (1.2), at least one volumetric sensor (1.4), and at least one inertial sensor (1.5).

3. The system according to claim 2, characterized in that, The processor (2.1) includes a signal compensation tool that attenuates noise based on an intracranial pressure signal, the noise being correlated with a signal detected by the contact sensor (1.2), the volumetric sensor (1.4), and / or the inertial sensor (1.5).

4. The system according to claim 2, characterized in that, The processor (2.1) or the receiver includes a channel signal quality index generation tool, wherein the tool generates quality indices based on signals from the displacement sensor (1.1), the contact sensor (1.2), the volumetric sensor (1.4), and / or the inertial sensor (1.5) of each biometric identification unit (1).

5. The system according to claim 1, characterized in that, The selector element selects one or more signals from each biometric identification unit (1) and allows the signals to be processed and / or analyzed globally, locally, or precisely, where global means all signals are read and processed, local means only some signals from one or more specific regions of the skull, and precise means signals from a single sensor.

6. A multi-channel device for non-invasive intracranial pressure detection and monitoring, characterized in that, The device includes: a. A plurality of biometric identification units (1) communicating with at least one processing unit (2), the processing unit (2) including a processor (2.1) communicating with a communication interface (2.2) for reading and processing signals from each biometric identification unit (1); and b. A fixed structure (3) capable of being positioned on the user’s head, wherein the plurality of biometric identification units (1) are radially distributed along the fixed structure (3), and each biometric identification unit (1) individually performs detection of skull deformation related to the user’s intracranial pressure; The communication interface (2.2) is configured to receive signals of skull deformation from each biometric identification unit (1); Each biometric identification unit (1) includes at least one displacement sensor (1.1) for detecting skull deformation related to intracranial pressure of the user, the displacement sensor (1.1) being attached to at least one unit support (1.3) associated with the fixation structure (3); and The processor (2.1) includes a selector element that selects signals of skull deformation from one or more biometric recognition units.

7. The multi-channel device according to claim 6, characterized in that, The processing unit (2) is positioned on the fixed structure (3).

8. The multi-channel device according to claim 6, characterized in that, The biometric identification unit (1) further includes at least one contact sensor (1.2), at least one volumetric plethysmography sensor (1.4), and at least one inertial sensor (1.5).

9. The multi-channel device according to claim 8, characterized in that, The contact sensor (1.2) and the volumetric sensor (1.4) are arranged in a first region (A) close to the user's head.

10. The multi-channel device according to claim 9, characterized in that, The first region (A) is opposite to the unit support (1.3), wherein the displacement sensor (1.1) is arranged between the first region (A) and the unit support (1.3).

11. The multi-channel device according to claim 8, characterized in that, The volumetric plethysmography sensor (1.4) is arranged to detect peripheral extracranial blood circulation (6) at a specific location on the user's head, wherein the detected data is used to exclude noise in the skull deformation signal detected by the displacement sensor (1.1).

12. A method for non-invasive multi-channel detection and monitoring of intracranial pressure in a user based on skull deformation, characterized in that, The method includes the following steps: a. Detect multiple signals of skull deformation of the user by means of a multi-channel device for detecting and monitoring intracranial pressure, including multiple biometric identification units (1) that can be positioned on the user's head; Among them, the signals of skull deformation are detected from different areas of the user's head, and each signal is detected by a displacement sensor (1.1) arranged at each biometric recognition unit (1); b. Receiving the plurality of signals related to the skull deformation via a communication interface (2.2), one or more of the plurality of signals related to the skull deformation being sent to a processor (2.1), wherein the communication interface (2.2) and the processor (2.1) are included in a processing unit (2), wherein the communication interface (2.2) is configured to receive signals from each biometric identification unit (1); and c. The processor (2.1) processes one or more signals related to the skull deformation that generates the intracranial pressure signal; The processor (2.1) selects one or more signals related to the skull deformation detected by one or more biometric identification units (1).

13. The method according to claim 12, characterized in that, The biometric identification unit (1) includes at least one contact sensor (1.2), at least one volumetric plethysmography sensor (1.4), and at least one inertial sensor (1.5).

14. The method according to claim 12, characterized in that, The method further includes the step of generating a channel signal quality index, which is generated for each of the plurality of signals associated with the skull deformation, wherein the channel signal quality index is generated based on a combination of displacement signals, contact signals, volumetric recording signals and / or movement signals detected by the plurality of biometric identification units (1), wherein the processor selects one or more signals associated with the skull deformation based on the quality index.

15. The method according to claim 12, characterized in that, The processor (2.1) selects signals from the skull deformation from each biometric identification unit (1) for global, local or precise processing of the signals, wherein global means all signals are read and processed, local means only some signals from one or more specific regions of the skull, and precise means signals from a single sensor.

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